- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07298746
Oct Angiography Changes After Local Anesthesia in Cataract Surgery
OCT Angiography Changes of Retinal Microvasculature After Local Anesthesia in Cases Undergoing Cataract Surgery
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: Local Anesthesia (peribular injection of both lidocaine 2 % and hyaluronidase 150IU\ML)
- Drug: Local Anesthesia (peribulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML)
- Drug: Local Anesthesia (retrobulbar anesthesia injection of lidocaine 2 % and hyaluronidase 150IU\ML)
- Drug: local Anesthesia (retrobulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML)
Detailed Description
prospective , interventional,comparative , clinical study utilizing a pre-post, within-subject design ,which will be conducted in the Department of Ophthalmology ,Sohag University Hospital ,Egypt.
Optical coherence tomography angiography (OCTA) will be performed before and after the administration of retrobulbar and peribulbar local anesthesia in the same cohort of patients, in order to evaluate the immediate effects of the anesthetic intervention on retinal microvascular parameters.the study will be conducted on patients aged 40-80 years with elective cataract surgery requiring regional block.the study will be divided into two main groups :
- Group with peribulbar anesthesia injection.
- Group with retrobulbar anesthesia injection.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amira aldesoky abdelazeem ahmed, resident
- Phone Number: 01055330581
- Email: amera.desouky@med.sohag.edu.eg
Study Contact Backup
- Name: Mohamed Anber Abdellatif, professor
- Phone Number: 01009801966
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patients aged 40-80 years.
- patients with elective cataract surgery requiring regional block.
Exclusion Criteria:
- 1.Allergy to study drugs. 2. Media opacities affecting OCT imaging (corneal pathologies, dense cataracts, vitreous.
opacities, etc). 3. Patients with any other retinal vascular diseases (retinal vein occlusion, central serous chorioretinopathy, age-related macular degeneration, etc).
4. Patients who have had previous intravitreal injections or Laser treatment. 5. Patients who underwent previous vitreoretinal surgeries. 6. Patients with uncontrolled glaucoma or ocular inflammations (eg: vitritis). 7.Patients with diabetes mellitus or hypertension.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: group A
peribulbar anesthesia injection of two anesthetic agents ( lidocaine 2 %+ hyaluronidase 150IU\ML )
|
peribular injection of both lidocaine 2 % and hyaluronidase 150IU\ML
|
|
Active Comparator: group A1
peribulbar anesthesia injection ( mepivacaine 2% + hyaluronidase 150IU\ML )
|
peribulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML
|
|
Active Comparator: group B
retrobulbar anesthesia injection ( lidocaine 2 %+ hyaluronidase 150IU\ML )
|
retrobulbar anesthesia injection of lidocaine 2 % and hyaluronidase 150IU\ML
|
|
Active Comparator: group B1
retrobulbar anesthesia injection ( mepivacaine 2% + hyaluronidase 150IU\ML )
|
retrobulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Macular superficial capillary plexus (SCP) and deep capillary plexus (DCP
Time Frame: ntervention & data collection :4-6 monthes
|
to detect degree of changes in vessel density at superficial and deep macular plexuses before and after injection of each group of anesthesia
|
ntervention & data collection :4-6 monthes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Rao HL, Pradhan ZS, Suh MH, Moghimi S, Mansouri K, Weinreb RN. Optical Coherence Tomography Angiography in Glaucoma. J Glaucoma. 2020 Apr;29(4):312-321. doi: 10.1097/IJG.0000000000001463.
- Ali H, Eissa S, Magdy H, Khashba M. Dexmedetomidine as an Additive to Local Anesthesia for Decreasing Intraocular Pressure in Glaucoma Surgery: A Randomized Trial. Anesth Pain Med. 2020 Jun 27;10(3):e100673. doi: 10.5812/aapm.100673. eCollection 2020 Jun.
- Kalra G, Zarranz-Ventura J, Chahal R, Bernal-Morales C, Lupidi M, Chhablani J. Optical coherence tomography (OCT) angiolytics: a review of OCT angiography quantitative biomarkers. Surv Ophthalmol. 2022 Jul-Aug;67(4):1118-1134. doi: 10.1016/j.survophthal.2021.11.002. Epub 2021 Nov 5.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-25-9-22MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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